MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD INSULIN PUMP; PUMP, INFUSION, INSULIN

Model Number 14000

Device Problems Loss of or Failure to Bond (1068); Unintended Movement (3026)

Patient Problems Hypersensitivity/Allergic reaction (1907); Caustic/Chemical Burns (2549)

Event Date 05/03/2022

Event Type  Injury  

Manufacturer Narrative

According to the complainant the device will not be returned for investigation.We are unable to determine if any product condition could have contributed to the reported chemical burn on the skin.Lot release records were reviewed and the product lot met all acceptance criteria.The omnipod is iso10993 compliant, undergoing cytotoxicity, sensitization, genotoxicity, hemolysis, irritation or intracutaneous reactivity, systemic toxicity, and implantation effects testing.The omnipod is sterilized with 100% ethylene oxide gas with a sterility assurance level of 10-6  per iso11135  and eo residual levels in compliance with iso10993.Each lot  is confirmed to meet requirements for non-pyrogenicity per iso10993 and sterility per iso11135 prior to release.

Event Description

It was reported that patient received a chemical burn at the infusion site due to pod wear.Patient reported that when pod comes into contact with water, he feels a burning sensation and the pod falls off within 30 minutes.In the time is takes to apply a new pod, patient's blood glucose levels rose into "the 200's" (mg/dl).No medical treatment was given due to this, but patient's doctor believed this was a type of reaction to the pod.

• Brand Name: OMNIPOD INSULIN PUMP
• Type of Device: PUMP, INFUSION, INSULIN
• Manufacturer (Section D): INSULET CORPORATION; 100 nagog park; acton MA 01720
• Manufacturer (Section G): INSULET CORPORATION; 100 nagog park; acton MA 01720
• Manufacturer Contact: michael spears ; 100 nagog park; acton, MA 01720 ; 9786007000
• MDR Report Key: 14453124
• MDR Text Key: 292219757
• Report Number: 3004464228-2022-08210
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385081120002
• UDI-Public: (01)20385081120002
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122953
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 14000
• Device Catalogue Number: ZXP425
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 23 YR
• Patient Sex: Male